Oral Polypodium Leucotomos for Melasma

University of Miami

Status: Completed

Conditions: Melasma

Treatments: Dietary Supplement: Polypodium Leucotomos; Dietary Supplement: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT01162850

20070050

Details and patient eligibility

About

Primary Objective: To determine whether there is improvement in the melasma of participants taking oral Polypodium Leucotomos Secondary Objective: To determine whether oral Polypodium Leucotomos is well tolerated in study subjects with melasma.

To determine whether treatment with Polypodium Leucotomos improves the health-related quality of life.

Full description

Polypodium Leucotomos is a fern, also known as Calaguala used by the natives of northern Honduras as a treatment against malignant tumors Used in Spain and Central America for the treatment of psoriasis, atopic dermatitis and repigmentation of vitiligo.

Oral Polypodium Leucotomos is safe and effective in patients with melasma.

Enrollment: 21 patients

Sex: Female

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy female subjects 18-50 years of age.
• Female subjects with epidermal melasma.
• Female subjects of child-bearing potential must have been willing to use an acceptable form of birth control for the duration of the study.
• Subjects with Fitzpatrick skin types II, III, & IV
• Subjects enrolled in this trial had a 2 week washout period if on prior treatment for melasma.

Exclusion criteria

• Pregnant or lactating
• Dermal Melasma
• Hormonal therapies less than or equal too 4 weeks prior to study
• Use of photosensitizing medications
• Simultaneous use of any form of treatment for melasma
• Subjects who were concurrently receiving light therapies
• Subjects who were unwilling to limit the amount of sun exposure
• Simultaneous ( or past 30 day) participation in a clinical research study.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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21 participants in 2 patient groups, including a placebo group

Polypodium Leucotomos

Active Comparator group

Description:

Oral Polypodium Leucotomos twice daily plus sunscreen SPF 45 for 12 weeks.

Treatment:

Dietary Supplement: Polypodium Leucotomos

Placebo

Placebo Comparator group

Description:

Oral Placebo twice daily plus sunscreen SPF 45 for 12 weeks.

Treatment:

Dietary Supplement: Placebo